Summary

for people ages 18 years and up (full criteria)
at UCSD
study started
estimated completion:
Sandip Patel (ucsd)

Description

Summary

In this study, Genocea is evaluating an investigational, personalized adjuvanted vaccine, GEN-009, that is being developed for the treatment of patients with solid tumors. A proprietary tool developed by Genocea, called ATLAS™ (Antigen Lead Acquisition System) will be used to identify neoantigens in each patient's tumor that are recognized by their CD4 and/or CD8 T cells. ATLAS-identified neoantigens will then be incorporated into a patient's personalized vaccine in the form of synthetic long peptides (SLPs).

Official Title

A Phase 1/2a Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine in Adult Patients With Selected Solid Tumors

Details

This first-in-human study of GEN-009 will be conducted in three parts in adult patients with cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, or renal cell carcinoma (Parts B and C only). In Part A, the safety and immunogenicity of single-agent GEN-009 will be evaluated in patients with the above-noted tumor types who have completed treatment with curative intent for their disease (eg, surgical resection, neoadjuvant and/or adjuvant chemotherapy, and/or radiation therapy) and have no evidence of disease (NED) at the time of initiating vaccination with GEN-009. In Part B, up to 15 patients in each disease cohort will be enrolled and evaluated for safety, immunogenicity, and preliminary antitumor activity of GEN-009. Patients in Part B will receive GEN-009 at the schedule selected in Part A, in combination with nivolumab at the approved dose and schedule per the United States Package Insert (USPI). Part C will evaluate the safety, immunogenicity, and objective response rate (ORR) of patients with the above-noted tumor types who have received at least 1 line of standard systemic therapy that included a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor for advanced, recurrent, or metastatic disease.

Keywords

Cutaneous Melanoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of the Head and Neck Urothelial Carcinoma Renal Cell Carcinoma Vaccine Personalized Immunotherapy Solid Tumor Personal Skin Lung Cancer Bladder Kidney Melanoma Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Renal Cell Carcinoma, Transitional Cell Head and Neck Neoplasms Vaccines Nivolumab GEN-009 Adjuvanted Vaccine

Eligibility

For people ages 18 years and up

General Inclusion Criteria:

  • Diagnosis of 1 of the following tumor types:
  • Melanoma (cutaneous).
  • NSCLC.
  • SCCHN (oral, oropharyngeal, hypopharyngeal, or laryngeal).
  • Urothelial carcinoma.
  • Renal cell carcinoma (Parts B and C only).
  • Understand the study, be willing to comply with all study procedures and sign the informed consent
  • Adequate tumor tissue available
  • ECOG performance status of 0 or 1
  • Negative pregnancy test (females of childbearing potential)
  • Agree to use of contraception during the study until at least 90 days after final GEN-009 dose
  • Adequate hematologic, liver, and kidney function

Part A-specific Inclusion:

  • Have completed or will complete treatment for their disease with curative intent
  • Have no evidence of disease

Part B-specific Inclusion:

  • Receiving or will initiate treatment with full-dose nivolumab per disease as listed below:
  • NSCLC: Patients with metastatic NSCLC with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have had disease progression on FDA-approved therapy for these aberrations prior to receiving nivolumab
  • SCCHN: Patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy
  • Cutaneous Melanoma: Patients with unresectable or metastatic cutaneous melanoma regardless of BRAF mutation status
  • Urothelial Carcinoma: Patients with locally advanced or metastatic urothelial carcinoma who:
  • Have had disease progression during or following platinum-containing chemotherapy
  • Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
  • Renal Cell Carcinoma: Patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
  • Disease assessment by CT or MRI
  • Have at least 1 lesion that is measureable by RECIST 1.1
  • Agree to a tumor biopsy 50 days after first GEN-009 vaccination
  • Participants with hypothyroidism must be on thyroid replacement treatment

Part C-specific Inclusion:

  • Have received at least 1 line of standard systemic therapy for advanced, relapsed, or metastatic disease
  • Have received a PD-1 or PD-L1 inhibitor either as a single-agent or in combination,and have had disease progression on the checkpoint inhibitor or disease that is considered by the Investigator to be refractory to the checkpoint inhibitor
  • In addition, Part C participants should have received the following chemotherapy:
  • NSCLC: A platinum-containing chemotherapy regimen
  • SCCHN: A platinum-containing chemotherapy regimen
  • Cutaneous Melanoma with a BRAF V600 mutation: An FDA-approved BRAF inhibitor
  • Urothelial carcinoma: A platinum-containing chemotherapy regimen.
  • Renal Cell Carcinoma: An anti-angiogenic therapy
  • Have at least 1 lesion that is measureable by RECIST 1.1
  • Agree to a tumor biopsy 50 days after first GEN-009 vaccination

General Exclusion Criteria:

  • Received a live vaccine ≤ 28 days, or a non-live vaccine ≤ 14 days, prior to the first dose of GEN-009
  • Acute or chronic skin disorders that would interfere with injection
  • Receiving immunosuppressive therapies or systemic corticosteroids. Note: Use of topical corticosteroids or inhaled corticosteroids is acceptable
  • Allergy to the vaccine adjuvant Hiltonol (poly-ICLC)
  • Active hepatitis B or hepatitis C infection
  • HIV Positive
  • History of clinically significant cardiac condition
  • History of leptomeningeal carcinomatosis
  • Had clinically active immune-mediated disease within 5 years
  • Received a prior allogeneic stem cell transplant
  • Has primary immune deficiency
  • Received a prior solid organ transplant
  • Has malignant disease, other than the tumor types being treated in this study
  • Female patient who is pregnant, breastfeeding, or who plans to become pregnant from the signing of the informed consent until ≥ 90 days from last dose of GEN-009
  • Any condition that in the judgment of the PI would make the patient inappropriate for enrollment in the study

Part A-specific Exclusion Criteria:

  • Has received or requires more than 2 adjuvant or neoadjuvant regimens (other than surgical excisions) given with curative intent prior to first GEN-009 vaccination
  • Has not recovered or stabilized from any clinically significant toxicity associated with any prior procedure or anticancer therapy

Part B-specific Exclusion Criteria:

  • Has received or requires additional anticancer treatment prior to first GEN-009 vaccination (however, these participants may be eligible for Part C)

Part C-specific Exclusion Criteria:

  • Has received or requires additional anticancer treatment within 14 days of first GEN-009 vaccination
  • Has not recovered or stabilized from any clinically significant toxicity associated with any prior procedure or anticancer therapy

Locations

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • John Wayne Cancer Institute - Providence Saint John's Health Center accepting new patients
    Santa Monica California 90404 United States

Lead Scientist

  • Sandip Patel (ucsd)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 15 research publications. Research interests: cancer immunotherapy · phase 1 clinical trials · cellular therapy · immunometabolism · microbiome · IDO · personalized medicine · precision medicine · CAR-T cell · NK cell · proteomics · immunotherapy

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Genocea Biosciences, Inc.
Links
OPDIVO (nivolumab) United States Prescribing Information
ID
NCT03633110
Phase
Phase 1/2
Study Type
Interventional
Last Updated